Medline PVP Solution Recalled Due to Mislabeled Sterility
Medline PVP Solution (REF DYNDA1858) is being recalled because it is labeled as sterile but contains non-sterile contents. 1,950 units are affected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving sterility mislabeling of a medical solution. While no hospitalizations or injuries have been reported, the product is a risk-of-harm device where non-sterile contents are mislabeled as sterile, meeting the rubric criterion for Score 3 (High).
Plain-English summary
Medline Industries, LP is recalling PVP Solution SING STRL (REF DYNDA1858) due to a labeling discrepancy. The product labeling indicates the contents are sterile, but the solution inside the foil sachet is actually non-sterile. This mismatch creates a risk of contamination and infection for users.
The recall affects 1,950 units distributed nationwide across Connecticut, Iowa, Louisiana, Massachusetts, Pennsylvania, California, New York, and Florida. Affected lot numbers are: 2023032090, 2023020990, 2022103190, 2022091690, 2022070190, 2022052090, 2022042290, 2022033190, 2021102290, and 2021092190. Products can be identified by UDI codes DI 40889942539858 (case) and 10889942539857 (each).
Healthcare facilities and consumers should immediately discontinue use of affected units. Contact Medline Industries or your healthcare provider for guidance on safe replacement or proper handling of the recalled product.
The recalled product
- Product
- PVP SOLUTION SING STRL, REF DYNDA1858
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 1,950
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (12)
- UDI/DI 40889942539858 (case)
- 10889942539857 (each)
- Lot numbers: 2023032090
- 2023020990
- 2022103190
- 2022091690
- 2022070190
- 2022052090
- 2022042290
- 2022033190
- 2021102290
- 2021092190
Distribution
Part of a larger recall action
This product is one of 7 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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